Development And Validation Of RP-HPLC Method For The Determination Of Lisinopril And Amlodipine In Bulk And Multicomponent Pharmaceutical Cardiovascular Dosage Form.
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Abstract
Objective: To develop a simple, accurate, linear, and precise RP-HPLC method for determination of Lisinopril and Amlodipine in bulk and multicomponent pharmaceutical cardiovascular tablet dosage form and validate as per the ICH guidelines.
Methods: In the methods used Phenomenex Luna C18(2) (250 x 4.6 mm, 5 µ) column, mobile phase Methanol: 0.1 % Perchloric Acid (52.5: 47.5%, v/v), the flow rate of 1 ml/min and the detection wavelength of 220 nm using PDA detector.
Results: The calibration curves were linear r2 = 0.999 and 0.999 in the concentration range of 40 to 60 ug/ml for both Lisinopril and Amlodipine. The developed method resulted in elution of Lisinopril at 2.11 min and Amlodipine at 4.65 min. The % recovery was found to be 99.97% to 100.09 % and 99.42% to 100.06% for Lisinopril and Amlodipine. The limit of detection was found to be 1.44 ug/ml and 2.62 ug/ml for Lisinopril and Amlodipine. The limit of Quantification was found to be 4.35 ug/ml and 7.94 ug/ml for Lisinopril and Amlodipine sequentially.
Conclusion: The present method of RP-HPLC was found to be accurate, simple and easy, specific, precise, linear, quick, and inexpensive. Within the concise analysis time, this method gives a superior resolution between both the compounds. That’s why the method to support good for the routine analysis of Lisinopril and Amlodipine in several pharmaceutical industries and also in academics.